Product Specialist Job at Orgenesis
About Koligo Therapeutics
Koligo Therapeutics, Inc. (“Koligo”) is a US regenerative medicine company developing and commercializing a range of tissue therapies for unmet medical needs. Koligo is unique in that, unlike most biotechnology companies, it has a product that is qualified for sale in the United States. Its first product Kyslecel® is an autologous pancreatic islet cell therapy used to treat chronic or recurrent acute pancreatitis, a debilitating and painful condition with few effective treatment options. Koligo commenced sales of Kyslecel® in November 2017. Short-term, Koligo is working on expanding its sales to a larger number of hospitals throughout the United States. Long-term, Koligo is developing a range of cell therapies, three-dimensional (3D) bioprinted tissue, and other regenerative medicine products.
Job Summary:
The Product Specialist assists in the production of Koligo’s main product, Kyslecel®. In this role, the individual will be involved in all aspects of Kyslecel® productionincluding preparation of the cleanroom, preparation of reagents, and participation in the processing of human tissue to produce the final product.
Job Duties:
- Complete and maintain training in all standard operating procedures necessary to produce the Kyslecel® product
- Maintain an inventory of necessary reagents, supplies and equipment
- Participate in the preparation of Kyslecel® in a cleanroom while maintaining sterile conditions
- Prepare and complete all paperwork, including Batch Production Records associated with each production run
- This position will report to the Laboratory Director
Essential Qualifications:
- Master’s degree and 1 year of biologic product manufacturing OR
- Bachelor’s degree and 3 years of biologic product manufacturing OR
- Associates degree and 5 years of biologic product manufacturing
- Excellent interpersonal skills; builds effective interactions with a broad range of internal and external organizations, teams, and individuals
- Excellent verbal and written communication skills
- Ability to think critically and takes collaborative approach to problem solving
- Ability to work effectively in regulated and fast paced environment
- Demonstrates high level of professional integrity and trustworthiness with strong work ethics
The ideal candidate would possess:
- Extensive working knowledge of cGMP/cGTP regulations
- Direct working experience in the field of cell and tissue therapy preferred
- Direct working experience in a cleanroom environment
Application:
To apply, go to www.koligo.net/careers and click the "Career Openings" link. This is a full-time position with competitive pay and benefits based on experience. Submit resume and cover letter for consideration. Only qualified candidates with acceptable employment eligibility verification (I-9) will be considered. Visa assistance not provided. Koligo reserves the right to fill this position with an internal or external candidate at any time during the search. Koligo is not responsible for unauthorized job postings or submissions of resumes using external links/websites.
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